Duns Number:140727624
Device Description: GP Drape with Custom Fenestration 38.5" x 60"
Catalog Number
396263
Brand Name
GP Drape
Version/Model Number
396263
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 10, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
d9a65ff4-a6f2-4ccc-b3a8-5c99447f5192
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
20886333212617
Quantity per Package
20
Contains DI Package
00886333212613
Package Discontinue Date
June 10, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |